Actively Recruiting
Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD Trial
Led by Wake Forest University Health Sciences · Updated on 2026-02-27
130
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
Sponsors
W
Wake Forest University Health Sciences
Lead Sponsor
N
National Institutes of Health (NIH)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a cardiovascular risk assessment protocol called EMERALD designed to improve preventive care for emergency department patients being assessed for acute coronary syndrome. The study aims to see if EMERALD reduces bad cholesterol levels (LDL-C and non-HDL-C) in patients at risk who are not already receiving preventive care, and to understand patient adherence and factors affecting implementation of heart disease prevention in the emergency setting. The EMERALD intervention includes ordering a lipid panel in the emergency department, calculating the 10-year risk of heart disease, prescribing moderate- or high-intensity statins based on risk, offering healthy lifestyle counseling, and ensuring patients connect with ongoing outpatient care through primary care or cardiology. Patients are randomized to either the EMERALD arm, which follows this protocol with tailored statin doses and referrals, or to usual care, which involves standard primary care referral without emergency department statin prescription but with lifestyle counseling. Participants will be monitored over 30 and 180 days to measure changes in LDL-C and non-HDL-C levels. Researchers will also track statin prescription pick-up and outpatient follow-up visits, assess barriers to care, and evaluate the effectiveness of the intervention in lowering cholesterol. The study includes regular assessments and aims to improve long-term cardiovascular prevention starting in the emergency setting.
CONDITIONS
Brief Title
Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Being evaluated for acute coronary syndrome
- Age between 40 and 75 years
- Having a 10-year atherosclerotic cardiovascular disease risk of 7.5% or higher, or known diabetes, or known atherosclerotic cardiovascular disease such as heart attack, unstable angina, coronary interventions, bypass surgery, stroke, transient ischemic attack, or peripheral artery disease
You will not qualify if you...
- Activation for ST-segment elevation myocardial infarction (STEMI)
- ST depression greater than 1 mm in contiguous leads
- Currently taking any lipid-lowering medications like statins, PCSK9 inhibitors, bempedoic acid, ezetimibe, or inclisiran
- Unable to return for 30-day follow-up
- Unstable vital signs such as low blood pressure, abnormal heart rate, or low oxygen levels
- Statin intolerance
- High-sensitivity troponin I levels of 100 ng/L or more
- End-stage kidney disease or very low kidney function
- Liver cirrhosis
- Pregnancy
- Anticipated hospitalization
- Life expectancy less than 1 year
- Transfer from another hospital
- Prisoner status
- Non-English speaking patients
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 180 days
Participants receive a statin medication (rosuvastatin 10 or 40 mg daily depending on risk) and healthy lifestyle counseling based on the American Heart Association's Life Essential 8 framework. They also receive referral to outpatient preventive care with primary care or cardiology, depending on their cardiovascular risk level.
1 baseline visit and follow-up visits through 180 days
Duration - Up to 180 days after treatment start
Participants are followed to assess changes in cholesterol levels and adherence to outpatient care referrals.
Visits at approximately 30 and 180 days
Trial Site Locations
Total: 1 location
1
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27517
Actively Recruiting
Research Team
L
Lauren Koehler
N
Nick Ashburn
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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